Drugs under experimental and clinical research
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Randomized Controlled Trial Clinical Trial
A placebo-controlled study of the efficacy and tolerability of a nonsteroidal anti-inflammatory drug, DHEP plaster, in inflammatory peri- and extra-articular rheumatological diseases.
A double-blind, randomized, placebo-controlled study has been carried out in order to assess the effects of the new topical cutaneous formulation, diclofenac hydroxyethylpyrrolidine (DHEP) plaster. Sixty patients (10 M + 50 F, mean age 56.6 yrs) suffering from local inflammatory processes in peri-articular/tendinous and/or extra-articular sites were involved in this study and randomly given either DHEP plaster or placebo plaster. Plasters were applied and left on the site of inflammation b.i.d. (at 8 a.m. and 8 p.m.) for 14 days. ⋯ Local inflammation, objectively evaluated using the telethermographic index, showed consistent reduction during the study which was statistically significant from day 3 onwards and significantly different compared to the control group. Global assessment of efficacy, expressed by the investigator and the patients, was significantly better (good to excellent after only 7 days in 70% of the cases) in the DHEP group compared to the placebo group. In the extra-articular pathologies, results similar to those reported earlier were obtained.(ABSTRACT TRUNCATED AT 250 WORDS)
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Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial
Clinical trial of the efficacy and safety of moguisteine in patients with cough associated with chronic respiratory diseases.
This completely randomised, double-blind, placebo-controlled, multicentre trial was carried out to evaluate the antitussive activity and safety of a 200 mg t.i.d. regimen of moguisteine (20 mg/ml ready-to-use suspension) during four days in patients with cough associated to chronic respiratory disorders. A total of 87 patients were enrolled, 42 on moguisteine and 45 on placebo. All had persistent dry or slightly productive coughs associated with chronic respiratory disorders. ⋯ The antitussive activity of moguisteine did not show remarkable variations either by diagnosis or by type of cough (dry/slightly productive). No serious adverse events were reported. No changes/trends were identified in laboratory tests that might indicate functional or toxic effects of moguisteine on specific organs.